Paradigm® REAL-Time Revel™ MMT-523RNAP (UDI 00643169476493)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523RNAP PRDGM V2.5B PL EN RH X7 · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Paradigm REAL-Time Revel insulin pump delivers insulin. The 24 reports mention high blood sugar with no-delivery alarms and parts cracking or not locking in place, plus unresponsive buttons, and include no deaths and 12 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169476493), received between May 26, 2017 and May 19, 2020 — classified as 12 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 reports).
14 other recalls cover devices cleared under the same FDA submission (P980022); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Patient Device Interaction Problem6
- No Apparent Adverse Event5
- Device Difficult to Program or Calibrate4
- Connection Problem2
- Obstruction of Flow2
- Priming Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Hyperglycemia12
- No Consequences Or Impact To Patient9
- Hypoglycemia4
- Death1
- Dizziness1
- Fainting1
- Loss of consciousness1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY COMPARTMENT HAD MISSING PIECES. CUSTOMER STATED INSULIN PUMP WAS ABLE TO LOCK IN PLACE WHEN INSERTED IN THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10068412 ↗MalfunctionApr 1, 2020Connection Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Connection Problem; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS OVER 400 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A BROKEN RESERVOIR RING. THE CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCK INTO PLACE. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9909461 ↗MalfunctionOct 31, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS HAD TO BE PRESSED MULTIPLE TIMES AT TIME. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD SEVERAL NO DELIVERY ALARMS AND SEEMS A BIT SLOWER WHILE PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9263948 ↗MalfunctionSep 25, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS HARDER TO PRESSED. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARM AND CRACKED NEAR THE BATTERY COMPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9114786 ↗MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP HAD TO PRESS HARDER TO FUNCTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9097011 ↗MalfunctionJun 21, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP RECEIVED MOTOR ERROR ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. DURING TROUBLESHOOTING, CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8721075 ↗MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE KEYPAD WAS UNRESPONSIVE. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8648702 ↗InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF AROUND 20 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT MENTION HOW THEY WERE TREATED. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FAINTING. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER DID NOT ALLEGE THE PUMP OVER DELIVERED INSULIN. THE CUSTOMER STATED THEY HAD CHANGED THEIR SETTINGS TO DELIVER LESS INSULIN FOR NOW. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Fainting; Hypoglycemia; Loss of consciousness
MAUDE report 8548437 ↗InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE CUSTOMER IS 400 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER REPORT CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DECLINED TO CHECK FOR THE PRESENCE OF LEAKS OR AIR BUBBLES IN THE TUBING OR RESERVOIR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8385129 ↗MalfunctionFeb 5, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PIECE WAS MISSING ON THE RESERVOIR COMPARTMENT AND RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP BECAUSE SURROUNDS THE RESERVOIR WAS MISSING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 85 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8309064 ↗InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO REPORT THE BLOOD GLUCOSE 390 MG/DL. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS OF HIGH BLOOD GLUCOSE. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8173062 ↗MalfunctionNov 5, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR COMPARTMENT BROKEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 215 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8036942 ↗MalfunctionOct 15, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND FAILED BATTERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 116 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND THE PUMP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7964012 ↗InjuryAug 20, 2018No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF THE 408 MG/DL AND DECLINED TROUBLESHOOTING FOR IT AND TREATED WITH BOLUS AND INJECTIONS. THE CUSTOMER ALSO STATED THAT, THE INFUSION SET HAD BENT CANNULA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7797349 ↗InjuryAug 15, 2018Power Problem; Power Problem
IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNEXPECTED BATTERY OUT LIMIT ALARMS. BLOOD GLUCOSE VALUE WAS 41 MG/DL AT THE TIME OF THE INCIDENT. NO HOSPITALIZATION OR MEDICAL ATTENTION WAS NEEDED FOR THE CUSTOMER. THE CUSTOMER STATED THEY FELT SLUGGISH AND TREATED WITH AN INSULIN SYRINGE. NO TROUBLESHOOTING WAS PERFORMED BECAUSE THIS WAS A PAST EVENT BEING REPORTED ON AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. NOTHING WILL BE REPLACED OR RETURNED.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 7784894 ↗InjuryAug 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 545 MG/DL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 323 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVEL WAS DUE TO HER NOT BEING ABLE TO UNLOCK HER PUMP BECAUSE IT WAS STUCK AND WOULD NOT WORK. TROUBLESHOOTING WAS PERFORMED FOR BATTERY OUT LIMIT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7780208 ↗InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND KETOACIDOSIS WITH BLOOD GLUCOSE OF 770 MG/DL, THE CUSTOMER CURRENT BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014. THE CUSTOMER WAS TREATED WITH EMERGENCY ROOM. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7389876 ↗InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER'S WIFE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE WAS 453 MG/DL. THE CURRENT BLOOD GLUCOSE IS 59 MG/DL. THE CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE WITH MANUAL INJECTION AND INSULIN DRIP. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7318040 ↗InjuryJan 31, 2018Insufficient Device Problem Information
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 26 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED GLUCOSE TABLETS AND WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED DUE TO BEING SICK. THE CUSTOMER BELIEVES THE SICKNESS CAUSED THE LOW. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7233084 ↗MalfunctionJan 9, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPICE CARE. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017. THE CAUSE OF DEATH WAS SMALL CELL LUNG CANCER. THE CALLER STATED THAT THE CUSTOMER HAD OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS OVER 500 MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE PUMP HAD BEEN DISCONNECTED WITHIN LESS THAN 48 HOURS PRIOR TO PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death; Hyperglycemia
MAUDE report 7176834 ↗MalfunctionNov 20, 2017Crack; Loose or Intermittent Connection
CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS DAMAGED. CUSTOMER BLOOD GLUCOSE WAS 59 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOT WAS PERFORMED. THE CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT WAS CRACKED AND THE HAD LOOSE PIECE. INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7046969 ↗InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A RECENT BLOOD GLUCOSE LEVEL OF 50 MG/DL, WHICH WAS TREATED WITH GLUCOSE TABS. CUSTOMER ALSO REPORTED BLOOD GLUCOSE LEVELS UP TO 483 MG/DL ON THE DAY OF THE CALL, WHICH WAS TREATED WITH THE INSULIN PUMP. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 444 MG/DL. LOW BLOOD GLUCOSE TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP DID NOT SHOW ANY MALFUNCTION DURING HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6711457 ↗InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND WANTED TO VERIFY THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 500 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 271 MG/DL. THE CUSTOMER STATED THEY WERE FEELING LIGHT HEADED. CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH READINGS. THE CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.
Patient problems: Dizziness; Hyperglycemia
MAUDE report 6692515 ↗InjuryMay 26, 2017Sticking; Device Inoperable
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE UNRESPONSIVE ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S HIGH BLOOD GLUCOSE WAS TREATED WITH A MANUAL INJECTION. THE CUSTOMER ALSO REPORTED THE TIME WAS ABLE TO ADVANCE ON THE INSULIN PUMP, BUT THE PUMP WAS STUCK ON REWIND DURING TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6595894 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.
- Z-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- Z-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-2442-2015 · Jul 22, 2015 · TerminatedGuardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
- Z-2179-2014 · Jul 21, 2014 · TerminatedMedtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
- Z-2544-2014 · Mar 13, 2014 · TerminatedMedtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K
Other Sensor, glucose, invasive devices
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- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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